COMPUTER SYSTEM VALIDATION (CSV) WORKFLOW

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[ ] Fetch System Requirements: Retrieve all User Requirements (URS) entries from the Requirements Data Model to initiate the validation scope.
[ ] Create Validation Plan Task: Assign a task to the QA Lead to draft the Validation Plan based on the identified system scope.
[ ] Generate Validation Plan Entry: Create a new entry in the Validation Plan data model containing the scope, strategy, and testing approach.
[ ] Risk Assessment Task: Assign a task to the Subject Matter Expert (SME) to perform a GAMP5-based risk assessment.
[ ] Create Risk Assessment Record: Create an entry in the Risk Management data model to document identified hazards and mitigation strategies.
[ ] Calculate Risk Priority Number (RPN): Execute formula (Severity * Occurrence * Detectability) to determine the critical level of each risk.
[ ] Update Risk Mitigation Status: Update the Risk Assessment entry to reflect that mitigation controls have been implemented.
[ ] Execute IQ/OQ/PQ Testing: Assign testing tasks to Validation Engineers to execute Installation, Operational, and Performance Qualifications.
[ ] Create Test Script Entry: Create a record in the Test Script data model for each protocol being executed.
[ ] Log Test Results: Update the Test Script entry with pass/fail results and evidence links after execution.
[ ] Summarize Deviation Count: Aggregate the number of 'Fail' statuses from all Test Script entries to determine total deviations.
[ ] Investigate Deviations Task: Create a task for the Quality Engineer if the Deviation Count is greater than zero.
[ ] Create Deviation Report: Create an entry in the Deviation Data Model for every failed test case identified.
[ ] Close Deviations: Update the Deviation entries to 'Closed' once corrective actions are verified.
[ ] Generate Traceability Matrix Report: Create a report linking Requirements $\rightarrow$ Risks $\rightarrow$ Test Scripts to ensure full coverage.
[ ] Final Summary Report Review: Assign a task to the Quality Manager to review the final Validation Summary Report (VSR).
[ ] Create Validation Summary Report: Create the final record in the Validation Summary data model summarizing the entire process outcome.
[ ] Notify Stakeholders of Approval: Send an email to the Project Sponsor and IT Department once the VSR is approved and the system is released for production.
[ ] Update System Status to 'Validated': Update the Computer System entry in the Inventory Data Model to 'Validated' status.

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